Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaharacho, Sakyo, Kyoto 606-8507, Japan.
Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaharacho, Sakyo, Kyoto 606-8507, Japan; Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo 675-1332, Japan.
J Infect Chemother. 2020 Feb;26(2):181-187. doi: 10.1016/j.jiac.2019.08.005. Epub 2019 Aug 28.
Treatment of aspiration pneumonia is an important problem due to aging of populations worldwide. However, the effectiveness of cefepime in aspiration pneumonia has not yet been evaluated.
To compare the clinical efficacy and safety of cefepime and meropenem in patients with moderate-to-severe aspiration pneumonia.
In this open-label, randomized study, either cefepime 1 g or meropenem 0.5 g was administered intravenously every 8 h to patients with moderate-to-severe community-acquired or nursing-home acquired pneumonia at risk for aspiration for an average of 10.5 days. The primary outcome was the clinical response rate at the end of treatment (EOT) in the validated per-protocol (VPP)-population. Secondary outcomes were clinical response during treatment (days 4 and 7) and at the end of study (EOS) in the VPP-population, and survival at day 30 in the modified intention-to-treat (MITT)-population.
There was no difference between the groups in the primary or secondary outcomes or safety. Significant improvement was observed in each group on day 4.
Cefepime is as effective and safe as meropenem in the treatment of moderate-to-severe aspiration pneumonia.
UMIN000001349.
由于全球人口老龄化，治疗吸入性肺炎是一个重要问题。然而，头孢吡肟治疗吸入性肺炎的效果尚未得到评估。
比较头孢吡肟和美罗培南在中重度社区获得性或护理院获得性吸入性肺炎患者中的临床疗效和安全性。
在这项开放标签、随机研究中，中重度社区获得性或护理院获得性肺炎且有吸入风险的患者，每 8 小时静脉注射 1 克头孢吡肟或 0.5 克美罗培南，平均治疗 10.5 天。主要结局为治疗结束时（EOT）验证后的意向治疗（VPP）人群的临床应答率。次要结局为 VPP 人群治疗期间（第 4 天和第 7 天）和研究结束时（EOS）的临床应答率，以及改良意向治疗（MITT）人群第 30 天的生存率。
两组在主要或次要结局或安全性方面无差异。第 4 天，每组均观察到显著改善。
头孢吡肟治疗中重度吸入性肺炎的疗效和安全性与美罗培南相当。
UMIN000001349。
